IdentificationEvaporate to dryness 25 mL of the first alcohol solution of methyltestosterone obtained in the Assay: the IR absorption spectrum of a potassium bromide dispersion of the residue so obtained exhibits maxima at the same wavelengths as that of a similar preparation of USP Methyltestosterone RS.

Procedure for content uniformityTransfer 1 finely powdered Tablet to a 100-mL volumetric flask, add 50 mL of methanol, and shake by mechanical means for 60 minutes. Dilute with methanol to volume, and filter, discarding the first 20 mL of the filtrate. Dilute a portion of the subsequent filtrate quantitatively and stepwise, if necessary, with methanol to provide a solution containing about 10 µg of methyltestosterone per mL. Concomitantly determine the absorbances of this solution and a solution of USP Methyltestosterone RS in the same medium having a known concentration of about 10 µg per mL, in 1-cm cells at the wavelength of maximum absorbance at about 241 nm, with a suitable spectrophotometer, using methanol as the blank. Calculate the quantity, in mg, of C20H30O2 in the Tablet taken by the formula:

(T / D)C(AU / AS)

in which T is the labeled quantity, in mg, of methyltestosterone in the Tablet; D is the concentration, in µg per mL, of methyltestosterone in the solution from the Tablet, based on the labeled quantity per Tablet and the extent of dilution; C is the concentration, in µg per mL, of USP Methyltestosterone RS in the Standard solution; and AU and AS are the absorbances of the solution from the Tablet and the Standard solution, respectively.

AssayWeigh and finely powder not less than 20 Tablets. Weigh accurately a portion of the powder, equivalent to about 10 mg of methyltestosterone, and transfer to a 125-mL separator with the aid of about 5 mL of water. Extract with four 25-mL portions of chloroform, filtering each through chloroform-washed cotton. Evaporate the combined extracts on a steam bath, with the aid of a current of air, to dryness. Dissolve the residue in alcohol, transfer to a 50-mL volumetric flask, add alcohol to volume, and mix. Pipet a 5-mL aliquot into a 100-mL volumetric flask, add alcohol to volume, and mix. Concomitantly determine the absorbances of this solution and a solution of USP Methyltestosterone RS in the same medium having a known concentration of about 10 µg per mL, in 1-cm cells at the wavelength of maximum absorbance at about 241 nm, with a suitable spectrophotometer, using alcohol as the blank. Calculate the quantity, in mg, of methyltestosterone (C20H30O2) in the portion of Tablets taken by the formula:

C(AU / AS)

in which C is the concentration, in µg per mL, of USP Methyltestosterone RS in the Standard solution; and AU and AS are the absorbances of the solution from the Tablets and the Standard solution, respectively.